A phase 3, double-blind, randomized placebo-controlled efficacy and safety study of abiraterone acetate in chemotherapynaïve patients with mCRPC in China, Malaysia, Thailand and Russia

doi:10.1016/j.ajur.2017.01.002

Asian Journal of Urology, 2017, 4 (2): 75-85 doi: 10.1016/j.ajur.2017.01.002

Asian Focus

A phase 3, double-blind, randomized placebo-controlled efficacy and safety study of abiraterone acetate in chemotherapynaïve patients with mCRPC in China, Malaysia, Thailand and Russia

Dingwei Ye^a, Yiran Huang^b, Fangjian Zhou^c, Keji Xie^d, Vsevolod Matveev^e, Changling Li^f, Boris Alexeev^g, Ye Tian^h, Mingxing Qiuⁱ, Hanzhong Li^j, Tie Zhou^k, Peter De Porre^l, Margaret Yu^m, Vahid Naini^m, Hongchuan Liangⁿ, Zhuli Wuⁿ, Yinghao Sun^k

a Department of Urology, Fudan University Shanghai Cancer Center, Shanghai, China;
b Department of Urology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China;
c Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China;
d Guangzhou First Municipal People's Hospital, Guangzhou, Guangdong, China;
e Department of Urology, Russian Academy of Medical Sciences, Moscow, Russia;
f Department of Urology, Cancer Institute (Hospital), Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China;
g Department of Oncology, Moscow Oncology Research Institute, Moscow, Russia;
h Department of Stomatology, Beijing Friendship Hospital, Capital Medical University, Beijing, China;
i Department of Urology, Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital, Chengdu, Sichuan, China;
j Department of Oncology, Peking Union Medical College Hospital, Beijing, China;
k Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China;
l Department of Oncology, Janssen Research & Development, Beerse, Belgium;
m Department of Medical Oncology, Janssen Research & Development, San Diego, CA, USA;
n Department of Urology, Janssen Research & Development, Beijing, China

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Abstract Objective: This double-blind, placebo-controlled phase 3 study was designed to compare efficacy and safety of abiraterone acetate+prednisone (abiraterone) to prednisone alone in chemotherapy-naïve, asymptomatic or mildly symptomatic metastatic castrationresistant prostate cancer (mCRPC) patients from China, Malaysia, Thailand and Russia.
Methods: Adult chemotherapy-naïve patients with confirmed prostate adenocarcinoma, Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade 0-1, ongoing androgen deprivation (serum testosterone <50 ng/dL) with prostate specific antigen (PSA) or radiographic progression were randomized to receive abiraterone acetate (1000 mg, QD)+prednisone (5 mg, BID) or placebo+prednisone (5 mg, BID), until disease progression, unacceptable toxicity or consent withdrawal. Primary endpoint was improvements in time to PSA progression (TTPP).
Results: Totally, 313 patients were randomized (abiraterone:n=157; prednisone:n=156); and baseline characteristics were balanced. At clinical cut-off (median follow-up time:3.9 months), 80% patients received treatment (abiraterone:n=138, prednisone:n=112). Median time to PSA progression was not reached with abiraterone versus 3.8 months for prednisone, attaining 58% reduction in PSA progression risk (HR=0.418; p<0.0001). Abirateronetreated patients had higher confirmed PSA response rate (50% vs. 21%; relative odds=2.4; p<0.0001) and were 5 times more likely to achieve radiographic response than prednisonetreated patients (22.9% vs. 4.8%, p=0.0369). Median survival was not reached. Most common (10% abiraterone vs. prednisone-treated) adverse events:bone pain (7% vs. 14%), pain in extremity (6% vs. 12%), arthralgia (10% vs. 8%), back pain (7% vs. 11%), and hypertension (15% vs. 14%).
Conclusion: Interim analysis confirmed favorable benefit-to-risk ratio of abiraterone in chemotherapy-naïve men with mCRPC, consistent with global study, thus supporting use of abiraterone in this patient population.

Key words： Abiraterone Chemotherapy-naïve Metastatic castrationresistant prostate cancer Prostate specific antigen Prednisone

Received: 28 January 2016 Published: 08 May 2017

Corresponding Authors: Yinghao Sun,E-mail address:sunyh@medmail.com.cn E-mail: sunyh@medmail.com.cn

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	Dingwei Ye
	Yiran Huang
	Fangjian Zhou
	Keji Xie
	Vsevolod Matveev
	Changling Li
	Boris Alexeev
	Ye Tian
	Mingxing Qiu
	Hanzhong Li
	Tie Zhou
	Peter De Porre
	Margaret Yu
	Vahid Naini
	Hongchuan Liang
	Zhuli Wu
	Yinghao Sun

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Cite this article:

Dingwei Ye,Yiran Huang,Fangjian Zhou, et al. A phase 3, double-blind, randomized placebo-controlled efficacy and safety study of abiraterone acetate in chemotherapynaïve patients with mCRPC in China, Malaysia, Thailand and Russia[J]. Asian Journal of Urology, 2017, 4(2): 75-85.

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http://www.ajurology.com/EN/10.1016/j.ajur.2017.01.002 OR http://www.ajurology.com/EN/Y2017/V4/I2/75